Chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) pose a major health burden to the patients but also to the healthcare system because of their distorted healing capacity. This is mainly due to a prolonged treatment duration, high recurrence rates and substantial healthcare costs in wound care. Current guidelines exist that outline the standard wound care (SWC) in these patient groups but it often fails to achieve timely healing. Cold atmospheric plasma (CAP) is an emerging technology with promising antimicrobial and wound healing properties. In vitro and in vivo studies have highlighted the ability of CAP to reduce the bacterial biofilm load and stimulate tissue regeneration and microcirculation. This Randomized Controlled Trial (RCT) aims to evaluate the clinical effectiveness and cost-effectiveness of CAP in addition to SWC in patients with a DFU and VLU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
494
Cold Atmospheric plasma treatment in addition to standard wound care
Ulcer-free survival days
number of days within the follow-up period (until 26 weeks after the start of the treatment) where the participant is alive and has no ulcer on the same anatomical location of the same foot or limb
Time frame: 26 weeks
Quality of Life (QoL)
The quality of life will be determined using the questionnaires EQ-5D-5L (generic). EQ-5D-5L descriptive system is divided into five levels of perceived problems: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. LEVEL 1: no problem LEVEL 2: slight problems LEVEL 3: moderate problems LEVEL 4: severe problems LEVEL 5: unable to/extreme problems Best outcome is therefore a score of 1 in all categories (total score=5), and worst outcome is a score of 5 in all categories (total score=25).
Time frame: baseline, 13 weeks and 26 weeks
Wound Quality of Life (Wound-QoL)
The wound-QoL (wound-specific Quality of Life) will also be measured since complex wounds have a major impact on patients' well-being. The questionnaire is made of three subscales, body, psyche and everyday life. Answers to each item are coded with numbers (0='not at all' to 4='very much'). Minimal score is therefore 0 (no impairement) and maximal 17 (maximum impairement). The higher the outcome the worst the quality of life.
Time frame: baseline, 13 weeks, 26 weeks
Wound healing rate
is defined as the percentage of wounds that are healed
Time frame: 26 weeks
time to wound healing
defined as the period measured in days between the start of the treatment period and confirmed wound healing as defined under primary endpoint
Time frame: 26 weeks
Surface area reduction
defined as the percentage of wound area reduction, measured using the eKare insight app, which automatically measures the wound metrics. Surface area reduction can show the added value for wounds that are not healed
Time frame: 26 weeks
Recurrences
presence of an ulcer at the same anatomical location of the same foot or limb of the initially treated ulcer
Time frame: 26 weeks
Development of new ulcers
defined as a new break in the skin not classified as a recurrence, thus not on the same location as the initially treated ulcer
Time frame: 26 weeks
Wound pain
Chronic wound pain level is evaluated using question 1 of the Wound-QoL (quality of life) questionnaire to identify any reduction in wound pain. Answers are coded with numbers (0='not at all' to 4='very much'). Minimal score is therefore 0 (no impairement) and maximal 4 (maximum impairement). The higher the outcome the worst the pain level.
Time frame: 26 weeks
Wound infection
the percentage wound infections is another measure of treatment efficacy, as CAP is bactericidal, and may indicate potential for reduction in use of antibiotics
Time frame: 26 weeks
Occurence of adverse events
will be recorded according to article 80 of the Medical Device Regulation
Time frame: 26 weeks
presence of amputations
presence of amputations on the same limb as the treated ulcer, occurring during the treatment or follow-up period (classified as yes/no).
Time frame: 26 weeks
Cost of Care
the total healthcare costs related to the treatment of the ulcer during the treatment and follow-up period, including the costs of wound care materials, healthcare professional time, hospital visits, interventions and other medical resource use
Time frame: 26 weeks
Cost Effectiveness
the cost per unit of clinical benefit evaluated by comparing the total costs between the intervention and control group in relation to the primary outcome
Time frame: 26 weeks
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